NCT00203034已完成3 期
A Multicenter, US and Canada, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study, for the Efficacy, Tolerability and Safety of Rasagiline Mesylate in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 472
- 试验地点
- 4
- 主要终点
- Change from baseline in the mean total daily "OFF" time
研究概览
简要总结
Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either Rasagiline or Placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with idiopathic Parkinson's disease whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without any other known or suspected cause of parkinsonism.
- •Subjects must experience levodopa related motor fluctuations averaging at least 2.5 hours daily in the OFF state.
- •Subjects must be taking optimized levodopa/carbidopa or levodopa /benserazide carbidopa/levodopa therapy (based on investigator's judgment), stable for at least 14 days prior to baseline. Subjects must be receiving at least 3 daily doses of levodopa, not including a bedtime dose.
- •Selegiline must be discontinued for at least 90 days prior to baseline.
- •Subject must be age 30 or older.
- •Subjects must be willing and able to give informed consent.
排除标准
- •Subjects with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, chest x-ray, or ECG for Parkinson's disease [e.g., pallidotomy, thalamotomy, and deep brain stimulation (DBS)] within the 12 months preceding the Baseline visit.
- •Subjects who have undergone neurosurgical transplantation are excluded regardless of when the procedure(s) was performed. No programming changes are permitted in subjects who have undergone DBS.
- •Participation in a previous clinical trial of rasagiline. Concomitant therapy with MAO inhibitors, reserpine, methyldopa within the past three months, or treatment with an anti-emetic or neuroleptic medication with central dopamine antagonist activity with the past six months.
研究组 & 干预措施
Experimental 2
Experimental
1.0 mg rasagiline mesylate oral once daily
干预措施: 1.0 mg rasagiline mesylate (Drug)
Placebo
Placebo Comparator
Placebo Comparator
干预措施: Placebo (Other)
Experimental 1
Experimental
0.5 mg rasagiline mesylate oral once daily
干预措施: rasagiline mesylate (Drug)
结局指标
主要结局
Change from baseline in the mean total daily "OFF" time
时间窗: 26 weeks
次要结局
未报告次要终点
研究者
研究点 (4)
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